China’s patent and trademark office has upheld a key patent within the portfolio of CRISPR/Cas9 intellectual property belonging to Nobel Laureate Emmanuelle Charpentier, PhD, The Regents of the University of California, and University of Vienna (known collectively as CVC), and licensed for commercial use through ERS Genomics.

Dublin-based ERS Genomics said the China National Intellectual Property Administration (CNIPA) has upheld Patent No. CN201380038920.6, “Methods and Compositions for RNA-guided Target DNA Modification and for RNA-guided Transcription Regulation,” following an invalidation challenge.

That challenge, according to ERS, came from ToolGen, a Seoul-based developer of gene editing technologies. ToolGen claims that it was the world’s first filer of patents covering gene editing in eukaryotic cells using the CRISPR-Cas9 system.

“This patent covers compositions and methods for use of CRISPR/Cas9 gene editing in a variety of eukaryotic cells, in either dual-guide or single-guide format,” Michael Arciero, vice president IP & Commercial Development with ERS Genomics, told GEN.

ToolGen contested the Chinese patent’s novelty and inventive step during proceedings in China. The CNIPA rejected both challenges to patentability, and maintained that CVC’s priority application enabled uses of CRISPR/Cas9 in eukaryotic cells.

“The decision by the CNIPA fully upholding the patent further demonstrates its validity and value as part of the patent collection for use of the CRISPR/Cas9 technology,” ERS Genomics stated in announcing the Chinese decision recently.

China’s decision follows one made in December by the Japan Patent Office, which upheld JP6692856, a CVC-filed patent with claims that are similar to the Chinese patent.

ERS Genomics has licensed its portfolio of 89 patents to companies in over 90 countries through its direct license from Charpentier, and now has nearly 150 licenses in place worldwide.

CRISPR “uptake” in Asia

“We do see uptake of the technology increasing in Asia,” Arciero said. He cited ERS’ licensing of CVC CRISPR patents to numerous Asian companies. Most recently, the Japanese multinational firm Ricoh signed a nonexclusive licensing agreement with ERS Genomics in the U.S. and Japan that gives Ricoh access to the foundational CRISPR/Cas9 genome editing technology patents. 

“This demonstrates a global trend, and reinforces the importance of research organizations having the correct intellectual property rights in place when working with this technology,” Arciero added.

The CVC patents have faced numerous challenges from competing companies and researchers.

The European Patent Office (EPO) has affirmed two CVC patents known as EP2800 811 in 2020 and EP3401400 in 2022, though oral arguments for the appeal of these affirmations are scheduled for October.

However, another CVC European patent (EP3241902) covering claims to reduced activity by chimeric Cas9 was revoked by the EPO’s Opposition Division in 2021. Much of the subject matter in that patent is covered in additional pending applications including one patent that was recently granted, Arciero said.

In the U.S., the use of CRISPR-Cas9 in eukaryotic cells has been enmeshed in a nearly decade-long bitter battle royale over who invented the genome editing technology.

Fifteen CVC applications are involved in an interference proceeding initiated by the U.S. Patent Trial and Appeal Board (PTAB) that remains under appeal by CVC. The PTAB in 2022 decided a second patent interference process in favor of the Broad Institute, MIT, and Harvard over CVC. The first interference was decided in favor of the Broad, MIT, and Harvard in 2018.

However, another 55 U.S. patents filed by CVC which cover all aspects of the CRISPR/Cas9 cleavage complex in all cells have been awarded, and are not involved in the PTAB interference, according to ERS.

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